• The FDA’s Fast Track designation reflects LBS-007’s potential to address the significant unmet medical need in acute leukemia treatment.
  • LBS-007 is Lin BioScience’s investigational drug for acute leukemia.
  • A Phase 1/2 clinical trial is underway for patients with relapsed or resistant acute leukemias.
  • LBS-007, the company’s lead product, has also received orphan drug designations from the FDA for acute myeloid leukemia and acute lymphocytic leukemia.

TAIPEI CITY, Taiwan, Nov. 27, 2024 — Lin BioScience (6696. Taiwan OTC), a clinical-stage biopharmaceutical company developing novel treatments for acute leukemia, announced that its lead drug candidate, LBS-007, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia. Lin BioScience is conducting a Phase 1/2 trial of LBS-007 in patients with relapsed or resistant acute leukemias across the US, Australia, and Taiwan. The FDA has also granted LBS-007 orphan drug designation for acute myeloid leukemia and acute lymphocytic leukemia.

“We are very pleased with LBS-007’s early treatment response and potential effectiveness in addressing this critical unmet medical need,” said Dr. Tom Lin, Chairman of Lin BioScience. “The FDA’s Fast Track Designation is a major achievement, expediting the development of this promising therapy. We remain fully committed to providing life-changing treatments for patients.”

“In the Phase 1 dose escalation, we observed no definitely or probably related adverse effects across all patients receiving low to high doses, indicating a very well-tolerated and promising safety profile,” said Dr. Irene Wang, President & CSO of Lin BioScience.

About Fast Track Designation
The Fast Track process is designed to speed up the development and review of drugs for serious conditions with unmet medical needs. The goal is to provide patients with access to important new drugs sooner. Fast Track applies to a wide range of serious conditions. An unmet medical need exists when no treatment is available or when a new therapy offers potential advantages over existing treatments. Fast Track designation allows for more frequent FDA meetings and written communications, eligibility for Accelerated Approval and Priority Review (if applicable), and Rolling Review. This increased communication ensures rapid resolution of questions and issues, often leading to faster drug approval and patient access.

About LBS-007
LBS-007 is a naturally derived, non-ATP cell cycle inhibitor effective against various cancers. It works by blocking CDC7 kinase activity, a key regulator of the cancer cell cycle. By inhibiting CDC7, LBS-007 stops tumor cell proliferation and triggers cancer cell death. Preclinical studies have shown LBS-007’s potent activity against leukemia and multiple solid tumors.

Media Contact:
Serena Chen
CFO
Office: (02) 8780-5008
Email:

About Lin BioScience:
Founded in 2016, Lin BioScience (6696. Taiwan OTC) is a drug development company focused on developing first-in-class therapies for cancer, ophthalmology, and metabolic diseases. The Company is currently developing four main drug candidates: LBS-008 (for Geographic Atrophy [GA] in advanced dry age-related macular degeneration [AMD] and Stargardt Disease type 1 [STGD1]) and LBS-009 (for non-alcoholic steatohepatitis [NASH]), both developed by its subsidiary Belite Bio (NASDAQ: BLTE), as well as LBS-007 (for acute leukemia and solid tumors) and LBS-002 (for primary and metastatic brain cancers) developed by Lin BioScience.

LBS-008 has received Orphan Drug Designation (ODD) for the treatment of STGD1 from the U.S. FDA, the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It also has Fast Track Designation and Rare Pediatric Disease (RPD) designation from the U.S. FDA, and Sakigake Designation from Japan’s Ministry of Health, Labour and Welfare (MHLW). LBS-007 has also received ODD for acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), and Fast Track Designation for AML, from the U.S. FDA.

For more information, follow us on , or visit us at .

Disclaimer:
This press release and related information contain forward-looking statements subject to risks and uncertainties, including market factors and other factors beyond Lin BioScience’s control. These forward-looking statements are based on current predictions and assessments, and the Company does not undertake any obligation to update this information unless legally required.